Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth

NCT06644703 | Completed DMC

• 1 other identifier: 10.05.2025/144
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is: \- Does controlled irrigation with cold saline in total pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control group, after hemostasis was achieved, the coronal pulp cavity was irrigated with 2 °C saline solution for 5 minutes.

Conditions

Pulpitis - Irreversible

Keywords

Cryotherapy; Vital pulp therapy; Irreversibl pulpitis; Postoperative pain; Total pulpotomy

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.

  up to 72 hours

Study Arms (2)

Cryotherapy group

EXPERIMENTAL

After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit.

Other: Cryotherapy

Control group

NO INTERVENTION

After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit.

Interventions

Cryotherapy OTHER

The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes in cryotherapy group.

Cryotherapy group

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Teeth with
• moderate or severe pain
• diagnosed with symptomatic irreversible pulpitis
• no tenderness to percussion and palpation
• positive response to cold test and electric pulp test
• no signs of periapical pathology

You may not qualify if:

• Teeth which
• could not be restored or required post-core
• had periapical lesions,
• had poor periodontal status (pocket depth\> 4 mm),
• had negative responses to pulp sensitivity tests,
• had no pulp exposure after caries removing Patients who
• had no preoperative pain or had mild preoperative pain
• had bleeding disorders
• had systemic diseases such as immunosuppressive disease or diabetes

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye

Adana, 01250, Turkey (Türkiye)

Location

Related Publications (2)

• Akhil VS, Kumar V, Aravind A, Sharma R, Sharma S, Chawla A, Upadhyay AD, Logani A. Novel cryotherapy technique for pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis- a randomized controlled trial. Clin Oral Investig. 2024 Apr 26;28(5):275. doi: 10.1007/s00784-024-05661-y.

  PMID: 38668793 BACKGROUND

• Keskin C, Ozdemir O, Uzun I, Guler B. Effect of intracanal cryotherapy on pain after single-visit root canal treatment. Aust Endod J. 2017 Aug;43(2):83-88. doi: 10.1111/aej.12175. Epub 2016 Oct 4.

  PMID: 27699913 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hamdi Oğuz Yoldaş, DDS PHD

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cukurova University, Faculty of Dentistry

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 16, 2024
• Study Start: September 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)